NF-NAFLD: Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02213224

Collaborator

(none)

180

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this current study was to assess the therapeutic effects of perindopril and telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic effects of these two kind of drugs.

This study is a randomized parallel control clinical trial which would be carried out in Nanfang Hospital, Southern Medical University.

About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan and amlodipine three groups.

Condition or Disease	Intervention/Treatment	Phase
Nonalcoholic Fatty Liver Disease (NAFLD)	Drug: Perindopril Drug: Telmisartan Drug: Amlodipine	Phase 4

Detailed Description

Inclusion criteria:

18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD; The patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to participate in the trial and signed the informed consent.

Exclusion criteria:

There are no coexisting causes for chronic liver disease, such as viral, alcoholic,drug-induced and autoimmune liver diseases; Patients with diabetes mellitus; Patients with serious primary diseases; Patients with mental disorder or can not take the medicine regularly; Pregnancy and nursing mothers; Allergic constitution or intolerance to ACEIs or ARBs drugs. Outcome measures include Cap value of FibroScan,angiotensin II,IL-18，IL-1β,aminotransferase,lipids and HOMA-IR.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial

Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Perindopril Perindopril 4mg qd taken in the morning;	Drug: Perindopril Perindopril is a kind of angiotensin converting enzyme inhibitors (ACEIs) which has been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use. Other Names: Perindopril; brand name: Acertil, serial number:H20034053
Experimental: Telmisartan Telmisartan 80mg qd taken in the morning;	Drug: Telmisartan Telmisartan is a kind of angiotensin receptor blockers (ARBs) which has also been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use. Other Names: Telmisartan; brand name: Micardis, serial number:J20090089
Placebo Comparator: Amlodipine Amlodipine；5mg qd taken in the morning.	Drug: Amlodipine Amlodipine is also a kind of widely used first-line drugs for the treatment of hypertension, and there is no evidence showing that it is effective for NAFLD. Other Names: Amlodipine；5mg qd taken in the morning.

Arm

Intervention/Treatment

Experimental: Perindopril

Perindopril 4mg qd taken in the morning;

Drug: Perindopril

Perindopril is a kind of angiotensin converting enzyme inhibitors (ACEIs) which has been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.

Other Names:

Perindopril; brand name: Acertil, serial number:H20034053

Experimental: Telmisartan

Telmisartan 80mg qd taken in the morning;

Drug: Telmisartan

Telmisartan is a kind of angiotensin receptor blockers (ARBs) which has also been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.

Other Names:

Telmisartan; brand name: Micardis, serial number:J20090089

Placebo Comparator: Amlodipine

Amlodipine；5mg qd taken in the morning.

Drug: Amlodipine

Amlodipine is also a kind of widely used first-line drugs for the treatment of hypertension, and there is no evidence showing that it is effective for NAFLD.

Other Names:

Amlodipine；5mg qd taken in the morning.

Outcome Measures

Primary Outcome Measures

Cap value of FibroScan （dB/m） [48 weeks after the treatment]
FibroScan examination would be performed in all patients 48 weeks after administration of the drugs, and Cap value of FirbroScan will be recorded.

Secondary Outcome Measures

Angiotensin II [12, 24, 48 weeks after the treatment]
IL-18，IL-1β [12, 24, 48 weeks after the treatment]
aminotransferase [12, 24, 48 weeks after the treatment]
lipids [12, 24, 48 weeks after the treatment]
HOMA-IR [12, 24, 48 weeks after the treatment]
homeostasis model assessment of insulin resistance (HOMA-IR)
computed tomography value of liver [48 weeks after the treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD;
The patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to participate in the trial and signed the informed consent.

Exclusion Criteria:

There are no coexisting causes for chronic liver disease, such as viral, alcoholic,drug-induced and autoimmune liver diseases;
Patients with diabetes mellitus; Patients with serious primary diseases; Patients with mental disorder or can not take the medicine regularly;
Pregnancy and nursing mothers;
Allergic constitution or intolerance to ACEIs or ARBs drugs.